510(k) · Cleared
ClearedArteraAI Breast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artera, Inc. · SHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
Cleared on May 4, 2026 after a 136-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 4, 2026
- Review
- 136 days
- Class
- Class II
- Product code
- SHW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK254115 ArteraAI BreastArtera, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260023 TumorSight RiskSimBioSys, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260023TumorSight RiskSimBioSys, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K254115 | ArteraAI Breast | Artera, Inc. | 2026 | — |
| +1 | K260023 | TumorSight Risk | SimBioSys, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SHW device
- #1 K260023 TumorSight Riskscore 12.1 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260023 | TumorSight Risk | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K260023 (SimBioSys, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SHW devicesSHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHW
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHW
Too few SHW 510(k)s in any year since 2007 to give a median.
Recalls per year · SHW
No recall names SHW since 2007.
Adverse event reports per year · SHW
No MAUDE report names SHW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ArteraAI Breast is a software only device intended to analyze scanned histopathology whole slide image (WSI) from treatment-naïve breast resection specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. Additional inputs to ArteraAI Breast include the following physician-provided clinical variables: ● Age ● Tumor size ● Nodal status ArteraAI Breast provides 5- and 10-year risks of distant…
Read the full statement (141 words)
ArteraAI Breast is a software only device intended to analyze scanned histopathology whole slide image (WSI) from treatment-naïve breast resection specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. Additional inputs to ArteraAI Breast include the following physician-provided clinical variables:
● Age
● Tumor size
● Nodal status
ArteraAI Breast provides 5- and 10-year risks of distant metastasis and ArteraAI risk score for adult patients with HR+/HER2-, N0 or N1, early-stage invasive breast cancer without clinically or pathologically defined metastases after surgical tumor resection and who are candidates for standard of care adjuvant therapy. ArteraAI Breast is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors.
ArteraAI Breast is intended to utilize WSIs acquired from FDA-cleared interoperable scanners and file formats that have been validated for use with this device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K254115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254115: ArteraAI Breast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254115
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026